Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Formally-C0604MT2D | |||
| MK0431-021 | |||
| 2006_413 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sitagliptin 100 mg/100 mg | Active Comparator | Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d ) |
|
| Sitagliptin 200 mg/200 mg | Active Comparator | Phase A and B: Oral tablets of sitagliptin 200 mg q.d |
|
| Placebo/Sitagliptin 100 mg | Placebo Comparator | Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d. |
|
| Placebo/Sitagliptin 200 mg | Placebo Comparator | Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sitagliptin (MK0431) | Drug | Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in A1C at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Weeks 0-24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in FPG at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. | Weeks 0-24 |
| Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17130196 | Background | Aschner P, Kipnes MS, Lunceford JK, Sanchez M, Mickel C, Williams-Herman DE; Sitagliptin Study 021 Group. Effect of the dipeptidyl peptidase-4 inhibitor sitagliptin as monotherapy on glycemic control in patients with type 2 diabetes. Diabetes Care. 2006 Dec;29(12):2632-7. doi: 10.2337/dc06-0703. |
Not provided
Not provided
Patients 18-75 years not on an antihyperglycemic agent (AHA) or on oral single AHA or low-dose combination therapy were eligible to participate. Following a screening diet/exercise period of variable duration, patients with hemoglobin A1c (A1C) 7-10% were eligible to enter a 2-week placebo run-in/wash-off period prior to randomization.
First Patient In: 08-Jul-2004; Last Patient Last Visit: 07-Feb-2007; One hundred eleven medical clinics worldwide (56 in the United States and Puerto Rico, 16 in 6 countries in Europe and 39 in 11 countries in the rest of the world).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Sitagliptin 100 mg/100 mg | The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| FG001 | Sitagliptin 200 mg/200 mg | The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| FG002 | Placebo/Sitagliptin 100 mg | The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period. |
| FG003 | Placebo/Sitagliptin 200 mg | The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Sitagliptin 100 mg | The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| BG001 | Sitagliptin 200 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in A1C at Week 24 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Weeks 0-24 |
|
Weeks 0-104
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sitagliptin 100 mg/100 mg | The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068900 | Sitagliptin Phosphate |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Sitagliptin | Drug | Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. |
|
|
| Placebo | Drug | Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks. |
|
| Placebo | Drug | Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks. |
|
| Metformin - Rescue | Drug | Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication. |
|
|
Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.
| Weeks 0-24 |
| Change From Baseline in A1C at Week 104 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent. | Weeks 0-104 |
| Change From Baseline in FPG at Week 104 | Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG. | Weeks 0-104 |
| Change From Baseline in 2-hr PMG at Week 104 | Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG. | Weeks 0-104 |
| Lack of Efficacy |
|
| Lost to Follow-up |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Site terminated |
|
| Protocol specified discontinuation |
|
| Patient moved |
|
| Patient was non-compliant |
|
| Recommendation of Primary Care Physician |
|
| Other |
|
The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| BG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Fasting Plasma Glucose (FPG) | Mean | Standard Deviation | mg/dL |
|
| Hemoglobin A1c (A1C) | Mean | Standard Deviation | Percent |
|
| OG001 | Sitagliptin 200 mg | The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). |
| OG002 | Placebo | The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period. |
|
|
|
| Secondary | Change From Baseline in FPG at Week 24 | Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG. | The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-24 |
|
|
|
|
| Secondary | Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 | Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG. | The all-patients-treated population included all patients with at least one dose of double-blind study therapy, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-24 |
|
|
|
|
| Secondary | Change From Baseline in A1C at Week 104 | A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent. | The all-patients-treated population for Week 104 included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | Percent | Weeks 0-104 |
|
|
|
| Secondary | Change From Baseline in FPG at Week 104 | Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG. | The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-104 |
|
|
|
| Secondary | Change From Baseline in 2-hr PMG at Week 104 | Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG. | The all-patients-treated population for Week 104, included all patients with at least one dose of double-blind study therapy after Week 24, and with a baseline value and ≥1 post-baseline value for this outcome. Data following glycemic rescue were treated as missing. Missing data were handled using the last observation carrying forward method. | Posted | Least Squares Mean | 95% Confidence Interval | mg/dL | Weeks 0-104 |
|
|
|
| 24 |
| 238 |
| 127 |
| 238 |
| EG001 | Sitagliptin 200 mg/200 mg | The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period). | 25 | 250 | 137 | 250 |
| EG002 | Placebo/Sitagliptin 100 mg | The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period. | 10 | 130 | 70 | 130 |
| EG003 | Placebo/Sitagliptin 200 mg | The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period. | 13 | 123 | 65 | 123 |
| Angina Unstable | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Atrial Fibrillation | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Coronary Artery Disease | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Myocardial Infarction | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Myocardial Ischaemia | Cardiac disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Borderline Glaucoma | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abdominal Strangulated Hernia | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholecystitis Acute | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Gallbladder Necrosis | Hepatobiliary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Sarcoidosis | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Abscess Of Salivary Gland | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Bronchitis Acute | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Lobar Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Pneumonia Legionella | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Staphylococcal Abscess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Staphylococcal Infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Urethritis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Anaesthetic Complication | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Foreign Body Trauma | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Lung Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Radial Nerve Injury | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Skin Laceration | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
|
| Hepatic Enzyme Increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Lipase Increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Cervical Spinal Stenosis | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Adrenal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Basal Cell Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Benign Renal Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Colon Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Lung Adenocarcinoma Stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Mesothelioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Rectal Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Rectal Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Renal Cell Carcinoma Stage Unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Lacunar Infarction | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Transient Ischaemic Attack | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Suicidal Behavior | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Suicidal Ideation | Psychiatric disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Vaginal Cyst | Reproductive system and breast disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Deep Vein Thrombosis | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
|
| Blood Glucose Increased | Investigations | MedDRA 9.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.1 | Non-systematic Assessment |
|
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D004700 | Endocrine System Diseases |
| D011719 |
| Pyrazines |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline FPG |
| <0.001 |
| Mean Difference (Net) |
| -21.3 |
| Standard Error of the Mean |
| 3.5 |
| 95 |
| -28.2 |
| -14.4 |
| No |
| Superiority or Other |
Model terms: treatment, presence/absence of prior diabetes pharmacotherapy, baseline 2-hr PMG |
| <0.001 |
| Mean Difference (Net) |
| -54.1 |
| Standard Error of the Mean |
| 6.4 |
| 95 |
| -66.7 |
| -41.6 |
| No |
| Superiority or Other |